Clinical Data Specialist

Project Role: Clinical Data Specialist

Work Experience: 1.5 - 4 Years

Work location: Homebased

Work Mode: Remote

Must Have Skills: Clinical data management, Veeva, Startup, Conduct and Closeout.

Job Overview

Experience & Background

• 4–6 years of hands-on Clinical Data Management experience in study start-up, study execution, and closeout activities.
• Strong exposure to Veeva EDC is highly preferred.
• Experience with eCOA and third-party data reconciliation, and SAE reconciliation (optional but beneficial).
• Ability to work independently while effectively collaborating with global teams.

Technical & Functional Skills:

• Ensure data acquisition, database design, edit check specifications, eCOA integration, and observed dataset requirements aligned with protocol objectives.
• Proficiency in tracking, monitoring, and reporting key metrics across study build, execution, and data delivery.
• Experience in data validation, discrepancy management, listings review, and QC activities. Strong understanding of integration of disparate data sources into unified datasets for analytics and decision-making.
• Therapeutic knowledge sufficient to perform high-quality data review and identify protocol-relevant trends or issues. Understanding of the technology ecosystem used for clinical data review to ensure accuracy and consistency of database deliverables.

Educational Qualifications:

• Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT).
• Minimum of 5 years of data management experience.
• Project management experience is required.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
• Oncology, endocrine and/or inflammatory therapeutic area experience is preferred.